The PS² project is transforming pharmacovigilance (PV) by creating shared standards for systems and processes, starting with Case Intake. This collaborative effort will reduce costs, eliminate duplication, and improve interoperability across the industry, while enabling faster solution evaluation and greater innovation. By focusing on common requirements and vendor certification, PS² allows pharma companies, suppliers, consultants, and service providers to spend less time on maintenance and more time advancing patient safety.
Resource Tag: Accelerate Late-Stage R&D
Pharmacovigilance Systems & Processes Standards (PS2) – Case Intake
Breaking Down Silos. Building Standards. Driving Innovation.
Pharmacovigilance (PV) systems across the pharmaceutical industry share remarkably similar requirements—but suffer from poor interoperability, leading to fragmented solutions, inflated costs, and limited innovation.
Join us for a focused webinar introducing the PS2 – Case Intake initiative aimed at defining requirements and integration standards for the pharmacovigilance case intake process. This effort seeks to reduce duplication, foster compatibility across PV technologies, and lay the groundwork for a more agile and cost-effective ecosystem.
In this session, we will:
- Present the project’s background, highlighting the current pain points in PV systems
- Share the objectives and scope of the initiative, including our approach to stakeholder collaboration
- Provide a summary of progress to date and outline the next steps
- Explain how both pharma companies and PV technology vendors can participate and contribute
Whether you’re a pharmacovigilance business lead, IT lead, or technology supplier, this webinar will equip you with the insights needed to decide if this initiative aligns with your organization’s strategic interests.
Speakers
- Thomas Kuckuk / Novartis / Head Pharmacovigilance Systems Management
- James John / AbbVie / Director of IT – Pharmacovigilance Patient Safety
- Henrik Lynge / Novo Nordisk / VP, Head of Architects & Strategy in Clinical Development
- John Wise / Pistoia Alliance / Member Services Consultant
Moderation: Marc Graber / Pistoia Alliance / PS2 – Case Intake Project Lead
Patients Can’t Wait – Smarter, Faster, Better Research Begins with You
Pistoia Alliance 2025 London conference presentation by Yvonne Diaz, Co-Founder & Chair, Oncogene Cancer Research
Real World Data (RWD) Quality Considerations for Regulatory Purposes
Pistoia Alliance 2025 London conference presentation by Puja Miles, Director, Clinical Practice Research Datalink
Transforming R&D with Integrated Human Health Data
Overview
Join the Pistoia Alliance and ZS Associates for a thought-provoking panel discussion on our white paper that envisions a future where seamless integration of research, clinical, and real-world data (RWD) drives groundbreaking advancements in R&D and personalized medicine.
This webinar brings together industry leaders to discuss:
- The current landscape of health data integration.
- Barriers—organizational and technical—that must be addressed.
- Use cases and transformations needed to realize this future.
Key Takeaways
- Insights from 25+ interviews with C-suite and R&D experts.
- Strategies for aligning people, processes, technology, and data.
- Opportunities to collaborate on initiatives to FAIRify data and advance innovation.
- View and download the report here
Host & Panelists
- Host – Becky Upton, President, Pistoia Alliance
- Panelist – Julie Huxley-Jones, Vice President Research. + Manufacturing Technology, Vertex
- Panelist – Bill Mayo, Senior Vice President Research IT, Bristol Myers Squibb
- Panelist – Bruce Press, Parter/Principle, ZS Associates
Who Should Attend
This webinar is designed for professionals in R&D, data science, healthcare, and anyone passionate about driving innovation through collaboration.
Let’s build a future where life sciences R&D is faster, more efficient, and focused on delivering better outcomes for patients worldwide.
Systematic Multi-Omics Analyses of Age-Related Diseases Suggest Shared Mechanisms
Pistoia Alliance 2025 London conference poster by Queen Mary University of London
Pistoia Alliance Annual Report 2023/24
Patient Listening on Social Media for Patient-Focused Drug Development.
Patients, life science industry and regulatory authorities are united in their goal to reduce the disease burden of patients by closing remaining unmet needs. Patients have, however, not always been systematically and consistently involved in the drug development process. Recognizing this gap, regulatory bodies worldwide have initiated patient-focused drug development (PFDD) initiatives to foster a more systematic involvement of patients in the drug development process and to ensure that outcomes measured in clinical trials are truly relevant to patients and represent significant improvements to their quality of life.
Patient Listening on Social Media for Patient-Focused Drug Development
A synthesis of considerations from patients, industry and regulators
Strategic Priorities Update February 2024
Join us for this inaugural update on the newly formed Strategic Priorities of the Pistoia Alliance, followed by a 30 minutes Q&A with our panelists
Agenda
Dr Becky Upton, President of the Pistoia Alliance
- Introduction
Dr Christian Baber, Chief Portfolio Officer, Pistoia Alliance
- Strategic Priorities Overview
- Harnessing AI to Expedite R&D
- Delivering Data-Driven Value
Thierry Escudier, Portfolio Lead, Pistoia Alliance
- Accelerating Use of Real-World Data
- Sustainability Driven R&D
Medical Research Charities and Biopharmaceutical Companies as Partners in Patient-Centred R&D
The Pistoia Alliance gathered a number of UK MRCs focused on complex lifelong conditions. The group used workshops and an opinion questionnaire for a snapshot of how the charities believe their knowledge and patient experiences could contribute insights and efficiencies to commercial R&D.
Calls for life sciences to focus on patient centricity
The life sciences and healthcare industries should restructure around patient centricity, according to global not-for-profit the Pistoia Alliance.
The call follows a meeting at the Pistoia Alliance’s annual European conference in London where discussions around the sector’s position in the wake of the Covid-19 pandemic took place. Attendees at the meeting highlighted how advances in technology are helping patients become more empowered regarding their health.